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Lead, Clinical Asset Planning

Biogen
United Statesfull_timeVerifiedPosted 9 Feb 2023

About the role

Job Description

About This Role  

Responsible for ensuring continuous product supply while minimizing EEO.  Work with commercial/clinical teams and clinical supply managers to maintain high forecast accuracy for drug substance and drug product plans.  Develop manufacturing/inventory plan based on demand and CMC activities.  Actively work with Asset Team to minimize supply risks due to regulatory approval status.  Tracks and report progress to manufacturing plan.  Routinely identify and communicate any supply risks to management.  Recommend/implement corrective actions to maintain inventory targets and minimize supply risks.  Manage/support activities for new product launches/clinical studies and supply chain projects.  Support cross-functional projects such as cross-functional process/system integration. Develop short-, mid-, and long-range manufacturing plans.

What You’ll Do  

  • Maintain Asset Supply Continuity
  • Accountable for availability of API/DS/DP/FGI across all protocols
  • Complete and Maintain Rough Cut Capacity Plans (RCCP) DS, DP, and FGI (FG if applicable)
  • Manage DS/DP/FGI lifecycle management
  • Monitor DS/DP/FGI supply performance
  • Develop and maintain DS, DP, API, and FGI demand and update relevant systems
  • Asset Single Point of Contact
  • Participate in the CDT and Asset Teams
  • Provide program updates to leadership
  • Participate in the design of the DS/DP supply chain
  • Create DP, DS, and FGI item codes, formulas, and recipes

Qualifications

Required Skills  

  • Bachelor of Science or Bachelor of Arts required
  • Minimum 3 to 5 years applicable industry experience

Preferred Skills 

  • Supply chain background, clinical science or healthcare background preferred

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.  

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Company

Biogen

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